AB0505 INTEGRATIVE MEDICINE APPROACH TO SUSTAIN LONG-TERM CONTROL IN CHRONIC RA: AN OBSERVATIONAL PROSPECTIVE STUDY OF A COMBINATION REGIMEN OF CONVENTIONAL DMARD AND AYURVEDIC HERBAL DRUG
Authors: M. Saluja, K. Adam, R. Patil, A. Chopra
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Prolonged drug treatment in RA is complicated by related toxicity, inadequate efficacy, other health issues, cost, and compliance. Ayurveda (India) drugs (Ayur) have popularly treated arthritis since ancient times. Few controlled/extended drug studies, both as mono or combination (Ayur plus modern medicine/M-Med) showed impressive outcomes (especially safety). In 2018, we introduced limited integrative treatment in rheumatology practice (community) to improve the outcome of long-drawn chronic RA. We present preliminary experience. <h3>Objectives</h3> To evaluate the one-year outcome of a combination treatment of conventional DMARD with standardized Ayur (herbal drug) <h3>Methods</h3> Consenting patients of chronic RA and clinically well-controlled disease (last 6 months) were selected in no particular order; supervised ongoing standard care with DMARD with/without steroids (previous period, median 5.5 years). SC-1 (Ayur) was added in a fixed stable dose (1 gm tablet, bid); standardized medicinal plant extracts (1 tab contained 50 mg Withania somnifera, 500 mg Boswellia serrata, 50 mg Curcuma longa, 400 mg Phyllanthus emblica), as per Ayurveda pharmacopeia. M-Med (RA) were adjusted at 12-16 weeks intervals based on clinical judgment. Standard follow-up (FU) procedures included a predetermined routine drug toxicity checklist. An Excel (Microsoft) based analysis was performed; standard deviation in parentheses, single sample paired T-test (P, two-tailed). Disease activity was classified according to the standard DAS 28 score. 453 patients qualified (one-year uninterrupted combination treatment and sufficient data) for analysis: 32% remission, 38% low activity (LDA), and 30% borderline moderate activity (MDA). Six months prior, 51% of the latter cohort (mean DAS=3.33 (0.95) were in remission/LDA. <h3>Results</h3> At baseline, the median of age and RA symptom duration respectively was 56 years (12.5) and 11 years (7.4); 80% seropositive RF; 91 % erosive/RA deformity; mean pain VAS(10 cm line)=2.78(1.23), mean HAQ (validated Indian version, maximum score 24)=3.17 (2.95), mean DAS 28= 2.9(0.76), 47% steroids (mean daily dose ≤5 mg pred), median ESR=30(19.4), 22% Hydroxychloroquine, 22% Sulfasalazine,74% Methotrexate (mean 16.3 mg weekly (4.48), and Combo DMARD 23%. At 1 year FU, 57% were in remission, 31% in LDA, and 12 % MDA; median ESR=30 mm (18.8), mean DAS= 2.35 (0.87) (p=0.000), 14% Sulfasalazine, 18% Hydroxychloroquine, 49% steroid, 70 % Methotrexate (mean 15.5 mg (4.6). Though statistically significant, several changes (core variables) were small and clinically considered unimportant. 32% cohort reported brief arthritis flares (1-3) versus 40% in the previous year. 409 clinical adverse events/AE (none serious/hospitalization) were reported during the study period; 121 non-related (drugs), 68 unspecified drugs, 34 Hydroxychloroquine, 25 Sulfasalazine, 136 Methotrexate, and 21 SC-1 (mostly gut and dyspepsia, infrequent mild transaminitis); correspondingly 472 AE were reported in the previous year (non-SC-1). FU data will be presented. The absence of control, placebo response, and floor and ceiling effect (outcome) may complicate the clinical interpretation of the results. Patients continued to be followed till date. <h3>Conclusion</h3> SC-1 (Ayurveda) further improved disease control, albeit modest, and safety in long-drawn chronic RA when combined with ongoing standard modern drugs under prolonged rheumatology care. This augurs well for the future. But first, controlled evaluation (integrative medicine) studies are warranted. <h3>Reference</h3> [1]Chopra A et al. (Long-term therapy of Ayurvedic drug in RA). J Ayurveda Integr Med. 2018;9(3):201-208. DOI: 10.1016/j.jaim.2017.07.009 (ii) Chopra A et al. (Controlled Evaluation of Ayurvedic drug in RA). Clin Rheumatol 2012; 31: 259-69. <h3>Acknowledgements</h3> ARCF-CRD Pune India for unrestricted study grant and wholehearted participation of patients and clinical staff. <h3>Disclosure of Interests</h3> None Declared.